PLOURDE v. SORIN GROUP USA INC (2021)

MEMORANDUM AND ORDER ON DEFENDANTS’ MOTIONS TO STRIKE AND EXCLUDE, AND MOTION FOR SUMMARY JUDGMENT

Plaintiffs William Plourde and Freda Merrill (“Plaintiffs”) are the parents of Allison Plourde, who died in February 2014 after suffering complications during a surgery to remove an aortic bioprosthetic heart valve, the Sorin Mitroflow Aortic Pericardial Heart Valve (“Mitroflow”). Plaintiffs bring state law claims for breach of warranty, negligence, and failure to warn, and also assert a violation of the Massachusetts consumer protection statute, Mass. Gen. Laws ch. 93A, against Defendants Sorin Group USA, Inc. (“Sorin USA”), Sorin Group Canada Inc. (“Sorin Canada”), and Carbomedics, Inc. (collectively, “Defendants”), who manufacture and sell the Mitroflow. [ECF No. 45]. Currently before the Court are Defendants’ motion to strike Plaintiffs’ statement of undisputed material facts, [ECF No. 108], Defendants’ motions to exclude, [ECF Nos. 73, 76, 79], and Defendants’ motion for summary judgment, [ECF No. 82]. For the reasons set forth below, the motion to strike, [ECF No. 108], is GRANTED in part, the motions to exclude, [ECF Nos. 73, 76, 79], are DENIED as moot, and the motion for summary judgment, [ECF No. 82], is GRANTED.

I. PROCEDURAL BACKGROUND

Plaintiffs filed this action in Suffolk County Superior Court on January 13, 2017, [ECF No. 1-1], and Defendants removed the case to this Court on March 24, 2017, [ECF No. 1]. Defendants filed a motion to dismiss, [ECF No. 16], which the Court granted in part and denied in part on March 29, 2018, [ECF No. 26]. The Court allowed only those claims based on Defendants’ alleged duty under state law to report post-approval information and incidents to the Food and Drug Administration (“FDA”) to proceed. [Id. at 7 & n.3 (citing Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 348, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001)) (noting that Plaintiffs’ additional state law claims related to FDA approval process were preempted by federal law)]. In its Order, the Court noted that it was not determining that Massachusetts law imposed such a duty, only that Plaintiffs would be given an opportunity to demonstrate that such a duty exists under Massachusetts law. [Id. at 17]. Plaintiffs then filed a second amended complaint, [ECF No. 45], bringing the following claims: breach of warranty pre-premarket approval (“PMA”) (Count I); breach of warranty post-PMA (Count II); negligence (Count III); failure to warn pre-PMA (Count IV); failure to warn post-PMA (Count V); violation of Massachusetts General Laws Chapter 93A pre-PMA (Count VI); and violation of Massachusetts General Laws Chapter 93A post-PMA (Count VII).

On March 3, 2020, Defendants filed a motion for summary judgment, [ECF No. 82], which Plaintiffs opposed, [ECF No. 100]. Defendants replied, [ECF No. 107], and Plaintiffs filed a sur-reply, [ECF No. 115]. In connection with their motion for summary judgment, Defendants filed a motion to strike Plaintiffs’ statement of undisputed material facts, [ECF No. 108], which Plaintiffs opposed, [ECF No. 119]. Defendants then filed a supplemental reply, [ECF No. 120], which addressed issues raised in both their motion for summary judgment and their motion to strike.

In addition, Defendants filed motions to exclude testimony from Plaintiffs’ experts Madris Tomes and J. Lawrence Stevens, [ECF Nos. 73, 76], and to preclude Plaintiffs’ fact witness, Dr. Frank A. Pigula, from presenting expert testimony, [ECF No. 79]. Plaintiffs opposed the motions. [ECF Nos. 93, 95, 97]. Defendants filed a consolidated reply, [ECF No. 106], and Plaintiffs filed a sur-reply in support of their opposition to the motion to preclude Dr. Pigula, [ECF No. 114].

II. MOTION TO STRIKE

Defendants argue that Plaintiffs did not comply with Local Rule 56.1 because they failed to file a statement responding to Defendants’ statement of undisputed material facts (“SOF”) and instead filed their own, separate statement of undisputed material facts (“Separate SOF”). [ECF No. 109 at 1–3]; see [ECF No. 99 (Plaintiffs’ Separate SOF)]. Defendants now ask the Court to strike Plaintiffs’ Separate SOF and accompanying materials, which Defendants claim contain irrelevant information, and deem all facts set forth in Defendants’ SOF to be admitted. [ECF No. 109 at 3–4]. Plaintiffs counter that they did, ultimately, comply with the rule in filing a response to Defendants’ statement of undisputed facts (“SOF Response”), even if it was filed late. See [ECF Nos. 116, 119].

Local Rule 56.1 is “designed to function as a means of ‘focusing a district court's attention on what is—and what is not—genuinely controverted.’ ” Hernandez v. Philip Morris USA, Inc., 486 F.3d 1, 7 (1st Cir. 2007) (quoting Calvi v. Knox County, 470 F.3d 422, 427 (1st Cir. 2006)). In order to assist in that goal, Local Rule 56.1 requires a party opposing summary judgment to file a statement of disputed material facts in response to the moving party's statement of undisputed material facts. L.R., D. Mass 56.1. In addition, the rule makes clear that the statement must address each fact set forth in the moving party's statement and be limited to identifying facts that are in dispute. See id. When a party opposing summary judgment fails to dispute the facts presented by the moving party, those facts are deemed admitted. Id. (“Material facts of record set forth in the statement required to be served by the moving party will be deemed for purposes of the motion to be admitted by opposing parties unless controverted by the statement required to be served by opposing parties.”). “Where a party opposing a motion for summary judgment fails to comply with Local Rule 56.1, the court has the discretion to decide whether to impose the sanction of deeming the moving party's factual assertions to be admitted.” Butters v. Wells Fargo Advisors, LLC, 10-cv-10072, 2012 WL 5959986, at *2, 2012 U.S. Dist. LEXIS 167964, at *4 (D. Mass. Nov. 27, 2012) (citing Swallow v. Fetzer Vineyards, 46 F. App'x 636, 638–39 (1st Cir. 2002)).

Defendants correctly observe that Plaintiffs’ “submission of a separate statement of undisputed facts is not contemplated by the rule.” Terry v. SimplexGrinnell LP, No. 11-cv-40117, 2013 WL 1332240, at *1 (D. Mass. Mar. 28, 2013). As Plaintiffs note, however, once Defendants identified the error, Plaintiffs submitted their SOF Response, which responds to each fact set forth in Defendants’ SOF. [ECF No. 116]. Where Plaintiffs made efforts to correct their initial error, the Court “declines Defendants’ invitation to impose such a draconian sanction” as deeming all facts in Defendants’ SOF admitted. Garcia v. Garda Cl New Eng., No. 15-cv-13093, 2017 WL 6346723, *3, 2017 U.S. Dist. LEXIS 228584, *8 (D. Mass. Aug. 14, 2017). As to Plaintiffs’ Separate SOF, rather than strike it in its entirety, the Court “will not consider [Plaintiffs’] factual assertions to the extent that they are immaterial, or constitute conclusions of law.” Terry, 2013 WL 1332240, at *1. Accordingly, Defendants’ motion to strike, [ECF No. 108], is GRANTED in part.

III. MOTION FOR SUMMARY JUDGMENT

A. Factual Background

Except as otherwise noted, the following facts are undisputed.

The Mitroflow, a piece of bovine pericardium sewn onto a polyester stent, is intended to replace diseased, damaged, or malfunctioning native or prosthetic aortic valves. [ECF No. 84-1 ¶ 4 (“SOF”)]. Sorin Canada manufactures the Mitroflow and is responsible for reporting to regulatory authorities, and Sorin USA handled clinical, research and development, human resources, legal, sales, and marketing tasks. [Id. ¶¶ 1–2]. On October 23, 2007, the FDA granted Defendants’ PMA for the Mitroflow Model 12, which is a Class III device, [id. ¶¶ 3, 5], and on February 27, 2009, the FDA approved Defendants’ supplemental PMA for the Mitroflow Model LX, which is also a Class III device, [id. ¶¶ 5, 8]. The PMA process included the FDA's approval of the Mitroflow's warning label. [Id. ¶ 6]. When approving a device for marketing in the United States, the FDA requires manufacturers to comply with certain “conditions of approval” in order to maintain that approval. [Id. ¶ 7]. These conditions include submitting PMA supplements to the FDA before making any change that affects the safety or effectiveness of the device, including changes to the instructions for use (“IFU”). [Id. ¶ 13].

The IFU for the Model 12 and Model LX Mitroflow are the same and indicate that the Mitroflow “is intended for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves.” [SOF ¶¶ 9, 10]. There are no known contraindications for the Mitroflow. [Id. ¶ 11; ECF No. 116 at 1 (“SOF Response”); ECF No. 86-4 at 2]. The IFU contains the following statement:

WARNINGS AND PRECAUTIONS[:] Clinical experience described in the medical literature suggests that juvenile patients or patients who are undergoing chronic hemodialysis, who have parathyroid disease or impaired calcium metabolism, or who are 55 years of age or less may experience accelerated calcification of bioprosthetic heart valves ․

[SOF ¶ 12; ECF No. 84-6 at 2]. The FDA has never required Defendants to change the labeling on the Mitroflow, issue a warning about the Mitroflow, or recall any model of the Mitroflow. [SOF ¶¶ 14–16].

1. FDA's Adverse Event Reporting Process

The FDA's specialists review a device's labeling, research its history, and analyze trends in order to ensure that a device's warning reflects any adverse events and that these events occur at no greater than the expected rate. [SOF ¶ 17]. The FDA's publicly available MAUDE database is a repository for medical device reports submitted to the FDA by manufacturers, importers, device user facilities, health care professionals, patients, and consumers. [Id. ¶¶ 18, 20]. Submitting a medical device report, or the FDA's release of that information, is not an admission that a product, user facility, importer, distributor, manufacturer, or medical personnel caused or contributed to the event. [Id. ¶ 19].

The FDA also conducts periodic audits of device manufacturers to confirm that they are complying with relevant regulations and guidance. [SOF ¶ 21]. These include reviewing a manufacturer's complaint handling policies and procedures. [Id. ¶ 22]. Where a manufacturer, like Defendants, is also subject to the authority of international regulatory authorities, the FDA may accept audit reports from the Medical Device Single Audit Program, which was established by the International Medical Device Regulators Forum to allow manufacturers to complete a single audit that can be referenced by multiple regulatory authorities. [Id. ¶¶ 24–26].

2. Defendants’ Adverse Event Reporting and Review Process

Defendants developed a complaint handling and adverse event reporting protocol, which it periodically revises, in an effort to comply with the FDA's post-market reporting requirements, as well as requirements from other regulatory authorities. [SOF ¶¶ 27, 28; SOF Response at 1]. Event handling begins when Defendants are notified of customer feedback or a complaint. [SOF ¶ 29]. Defendants sometimes received customer feedback through its sales representatives, who submitted the feedback on a Field Experience Report Form. [Id. ¶¶ 30–31]. Upon receipt, Defendants document the feedback or complaint. [Id. ¶ 32]. Defendants have a cross-functional committee, the Field Events Review Committee (“FERC”), which meets weekly and determines whether an event is a complaint. [Id. ¶ 33]. Later, the FERC also determines whether Defendants are required to report the event to regulatory authorities. [Id.].

The FDA requires device manufacturers to report information suggesting that a device may have caused or contributed to a death or serious injury. [SOF Response at 2–3]. This requires manufacturers to perform a careful review of each incident it learns about and to determine whether it is reportable. [SOF ¶ 35]. In the context of this case, this review includes consideration of several factors, including the patient's medical history, the company's internal policies and procedures, applicable regulations, and the performance of tissue valves generally. [Id.]. If the FERC determines that it needs additional information to decide whether an event is reportable, it may ask a sales representative to go back to a user facility to obtain that information. [Id. ¶ 36].

Adverse events are reported to the FDA using the FDA's Form 3500A. [SOF ¶ 38]. Defendants state that, using the 3500A process, they submitted the events that met the FDA's reportability requirements but Plaintiffs claim that Defendants did not report all the events that they should have. [Id. ¶ 34; SOF Response at 2]. Even if a complaint was not submitted to the FDA on a Form 3500A, Defendants still included the event in its annual reports to the FDA. [SOF ¶ 41]. These annual reports are required by regulations and the conditions of approval for the Mitroflow. [Id. ¶ 39]. According to Defendants, between 2007 and 2012, they included a “summary of complaints” in the annual report that contained all Mitroflow-related complaints from the previous year. [Id. ¶ 40]. Plaintiffs argue that this summary omitted certain incidents that Defendants deemed to be “feedback” rather than reportable complaints. [SOF Response at 3]. Between October 2007 and June 2012, Defendants used a Form 3500A to report one adverse event for a patient under the age of thirty. [SOF ¶ 81]. That patient had required a Mitroflow explant one year after implantation. [Id.].

In January 2009, the FDA audited Sorin Canada and found no deficiencies. [SOF ¶¶ 42, 44]. Sorin Canada was also audited by a third party in 2010 and 2012. [Id. ¶¶ 45, 47]. During the 2012 third-party audit, auditors reviewed Defendants’ complaint handling and reporting procedures and concluded that “the rationale for considering a case as a feedback versus complaint was clear. The decision not to implement a corrected action was the result of the investigation.” [Id. ¶¶ 48–49]. The 2010 and 2012 auditors reported “a high level of confidence” in Defendants’ ability to satisfy regulatory requirements. [Id. ¶¶ 46, 50].

3. Accelerated Calcification in Tissue Valves

Many factors are relevant in selecting an appropriate valve for implantation, including a patient's age, lifestyle, ability to tolerate Coumadin, gender, size of the annulus, type of underlying disease, life expectancy, urgency of the replacement, and medical conditions which require calcium supplements. [SOF ¶ 51].¹ This is therefore an individualized assessment where no single factor is determinative. [Id. ¶ 52]. In addition, an aortic valve may act differently in different patients. [Id. ¶ 53].

It is common knowledge and a recognized characteristic of tissue valves that they degenerate faster in younger patients. [SOF ¶ 54]. Younger patients have more active bone turnover and increased cardiac output, which accelerate calcification of the valve. [Id. ¶ 56]. At his deposition, Plaintiffs’ expert Dr. Pigula testified that he does not like to use bioprosthetic valves in the aortic position because most of his patients are young and these valves typically fail. [Id. ¶ 55]. He learned about this tendency for failure when he was training as a physician in the 1990s. [Id. ¶ 57]. In addition, as of 2012, there was medical literature concluding that bioprosthetic valves degenerate faster in younger patients. [Id. ¶ 62]. For example, in February 2012, physicians from Boston Children's Hospital (“BCH”) published a study concluding that younger age at the time of a pulmonary valve replacement was a significant predictor of reduced time to structural valve deterioration. [Id. ¶ 64]. Dr. Pigula and Dr. Christopher Baird were co-authors on the study. [Id. ¶ 65]. Dr. Pigula noted that the study's conclusion was “consistent with the common knowledge that [bioprosthetic] valves deteriorate no matter what position they are in” (aortic or pulmonary), [id. ¶ 66 (alteration in original)], and Dr. Baird also observed that it is not unusual for bioprosthetic valves to fail, [id. ¶ 72]. BCH surgeons informed patients and their families that valves made from tissue are expected to deteriorate and will require replacement. [Id. ¶ 58]. Nonetheless, as doctors and the FDA knew, despite these risks, there were other reasons to select bioprosthetic valves for pediatric patients. [Id. ¶ 59].

Given that the Mitroflow was approved in 2007, there was not a significant amount of data on the Mitroflow's performance in younger patients as of 2012. [SOF ¶ 74]. Between October 2007 and June 2012, 179 Mitroflows were implanted in the aortic position in patients who were younger than 30. [Id. ¶ 78]. Defendants state that during that timeframe they received three reports from users about Mitroflow explants in patients who were under thirty at the time of implant, though Plaintiffs contend that other reports did not include the patient's age at implant. [Id. ¶ 79; SOF Response at 4]. In addition, while Defendants state that they followed their internal procedures for assessing whether to communicate these reports to the FDA, Plaintiffs challenge the sufficiency of the determinations that resulted from these internal procedures. [SOF ¶ 80; SOF Response at 4].

4. Allison's June 2012 Procedure

Allison was born in 1991 and had health complications from birth, including an interrupted aortic arch that required surgery when she was two weeks old. [SOF ¶¶ 82–84]. She was also diagnosed with DiGeorge Syndrome, which impacted her cognitive abilities. [Id. ¶¶ 86–87]. In 1997, 2000, and 2011, Allison underwent catheterizations in connection with her aortic valve, [id. ¶¶ 88–90], and in June 2012, Allison's mother was told that Allison would not survive without a valve replacement, [id. ¶ 92]. Allison was referred to BCH and transported there by ambulance. [Id. ¶ 94]. Dr. Baird was Allison's surgeon at BCH, and he explained the different valve options that were available to Allison and her family. [Id. ¶¶ 95–96]. His notes from these consultations indicate that he spent more than an hour with them discussing mechanical versus bioprosthetic valves, clinical data, treatment options, and coordination of care. [Id. ¶ 97]. Deciding on a tissue valve for Allison was due in part to the fact that a tissue valve would not require daily doses of Coumadin whereas a mechanical valve would. [Id. ¶ 98]. At the time, Dr. Baird was aware of the risks of early calcification of bioprosthetic valves in younger patients and it was his practice to warn patients and their families of this risk. [Id. ¶ 99]. It was also his practice to warn patients that bioprosthetic valves deteriorate faster than mechanical valves, and deteriorate faster the younger a patient is. [Id. ¶¶ 103–04].²

On June 19, 2012, Dr. Baird implanted the Mitroflow Model LX in Allison in the aortic position. [SOF ¶¶ 108–09]. It was his practice to review the IFU for heart valve devices that he intended to use, and he was familiar with the IFU for the Mitroflow. [Id. ¶¶ 100–01]. In addition, he relies on information from the FDA, such as recommendations to use or not use products, which he receives through medical societies. [Id. ¶ 107]. He does not know about the FDA's MAUDE database for adverse events. [Id. ¶ 106]. Dr. Baird's decision to implant the Mitroflow Model LX into Allison was based on studies and data that were available to him and the medical community, medical literature, the device's IFU, and his assessment of the options available for Allison. [Id. ¶¶ 73, 76].

Allison experienced several significant complications following the surgery, and underwent a follow-up surgery on June 28, 2012 to have a stent placed in her aorta. [SOF ¶¶ 111–13]. She was in the hospital until July 19, 2012 following her June surgeries. [Id. ¶ 114].

5. Subsequent Valve Failures in Patients Under Thirty Years of Age, Including Allison

On April 15, 2013, a thirteen-year-old BCH patient who had been implanted with a Mitroflow passed away and was the first reported death of a juvenile patient associated with the Mitroflow. [SOF ¶¶ 115–16]. BCH reported the event to the FDA, who then notified Defendants. [Id. ¶ 119]. In response to this event, BCH contacted patients who had been implanted with a Mitroflow in the aortic position when they were twenty-five years old or younger, including Allison. [Id. ¶¶ 117–18]. Between December 2013 and September 2015, BCH submitted reports to the FDA about some of those patients. [Id. ¶ 120].

On January 16, 2014, Allison underwent surgery, performed by Dr. Pigula, to explant the Mitroflow and replace it with a mechanical valve. [SOF ¶¶ 124, 129, 132]. The following day, Allison underwent catherization and a stent was placed in her left main coronary artery. [Id. ¶ 133]. According to Dr. Pigula, Allison was a complicated, high-risk patient with a very sick heart. [Id. ¶ 126]. The same complications that made her a high-risk patient prior to her June 2012 surgery were also present in January 2014. [Id. ¶ 127]. Dr. Pigula decided to implant a mechanical valve, after consultation with Allison and her family, because he did not think she could tolerate a subsequent surgery, let alone another explant and valve replacement surgery. [Id. ¶¶ 125, 128].

Sadly, after the January 2014 surgery, Allison experienced complications and never regained consciousness. [SOF ¶¶ 134–35]. She underwent another surgery on February 5, 2014 after the mechanical valve malfunctioned, and a replacement mechanical valve was implanted. [Id. ¶¶ 136–37]. Allison did not recover and was taken off life support on February 7, 2014. [Id. ¶ 140].

6. The FDA's Follow-Up on Mitroflow Failures

In March 2014, the FDA asked Defendants and BCH for additional information after the adverse events reported by BCH, and Defendants responded to those requests and provided the FDA with medical literature. [SOF ¶¶ 141, 145; ECF No. 87-20 at 2]. In June 2014, Defendants met with representatives from the FDA for an in-person meeting. [SOF ¶ 147]. In addition, Defendants also conducted an internal investigation in response to these events and formed a medical and scientific advisory board regarding the Mitroflow. [Id. ¶¶ 142–43]. The advisory board found Defendants’ quality system and procedures for complaint handling to be thorough and appropriate and concluded that rapid calcification of the Mitroflow when implanted in children was “not unexpected and should be anticipated by clinicians as reflected in the literature and data presented ․” [Id. ¶ 144]. Again, the FDA has never required Defendants to change the labeling on the Mitroflow, issue a warning about the Mitroflow, or recall any model of the Mitroflow. [Id. ¶¶ 14–16].

In April 2014, Defendants received FDA approval for a new valve, the Mitroflow DL, which contained anti-calcification technology. [ECF No. 99 ¶ 107; ECF No. 101-60 at 2]. Defendants replaced all Mitroflow LX stock with the new Mitroflow DL model and informed the FDA. [ECF No. 99 ¶ 108; ECF No. 101-61 at 2].

B. Legal Standard

Summary judgment is appropriate where the moving party can show that “there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.” Fed. R. Civ. P. 56(a). “To succeed in showing that there is no genuine dispute of material fact, the moving party must ․ ‘affirmatively produce evidence that negates an essential element of the non-moving party's claim,’ or, using ‘evidentiary materials already on file ․ demonstrate that the non-moving party will be unable to carry its burden of persuasion at trial.’ ” Ocasio-Hernández v. Fortuño-Burset, 777 F.3d 1, 4–5 (1st Cir. 2015) (quoting Carmona v. Toledo, 215 F.3d 124, 132 (1st Cir. 2000)).

[T]he plain language of Rule 56[ ] mandates the entry of summary judgment, after adequate time for discovery and upon motion, against a party who fails to make a showing sufficient to establish the existence of an element essential to that party's case, and on which that party will bear the burden of proof at trial. In such a situation, there can be no genuine issue as to any material fact, since a complete failure of proof concerning an essential element of the nonmoving party's case necessarily renders all other facts immaterial.

Delgado v. Aero Inv. Corp., 601 F. App'x 12, 15 (1st Cir. 2015) (quoting Celotex Corp. v. Catrett, 477 U.S. 317, 322–23, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986)).

In reviewing the record, the Court “must take the evidence in the light most flattering to the party opposing summary judgment, indulging all reasonable inferences in that party's favor.” Cochran v. Quest Software, Inc., 328 F.3d 1, 6 (1st Cir. 2003). The First Circuit has noted that this review “is favorable to the nonmoving party, but it does not give him a free pass to trial.” Hannon v. Beard, 645 F.3d 45, 48 (1st Cir. 2011). “The factual conflicts upon which he relies must be both genuine and material[,]” Gomez v. Stop & Shop Supermarket Co., 670 F.3d 395, 397 (1st Cir. 2012), and the Court may discount “conclusory allegations, improbable inferences, and unsupported speculation.” Cochran, 328 F.3d at 6 (quoting Medina-Muñoz v. R.J. Reynolds Tobacco Co., 896 F.2d 5, 8 (1st Cir. 1990)).

C. Discussion

1. Claims Pre-Dating 2007 PMA

As Defendants note, see [ECF No. 83-1 at 21 n.5], the Court dismissed Plaintiffs’ claims relating to conduct that occurred prior to the FDA's approval of the Mitroflow in 2007 after finding them preempted by federal law, [ECF No. 26 at 7 & n.3]. Plaintiffs’ second amended complaint re-pleads these claims, [ECF No. 45 ¶¶ 45–58, 87–100, 116–28], but Plaintiffs’ opposition to summary judgment does not reference them, which suggests that Plaintiffs understand that these claims are foreclosed, see generally [ECF No. 100]. Given the Court's prior ruling on this issue, Plaintiffs’ Counts I, IV, and VI, which make pre-PMA claims, are DISMISSED.

2. Overview of Preemption and the Court's Order on Defendants’ Motion to Dismiss

In its Order on Defendants’ motion to dismiss, the Court analyzed the preemption issue presented here. See generally [ECF No. 26]. The Court will therefore provide only a brief overview.

The Medical Device Amendments (“MDA”) to the Food, Drug, and Cosmetic Act require FDA approval before new medical devices are introduced into the market. Riegel v. Medtronic, Inc., 552 U.S. 312, 315, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008). The MDA contains an express preemption provision which provides that,

[e]xcept as provided in subsection (b) of this section, no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement—

(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and

(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.

21 U.S.C. § 360k(a).

In interpreting this provision, the Supreme Court has held that because “[s]tate requirements are preempted under the MDA only to the extent that they are ‘different from, or in addition to’ the requirements imposed by federal law,” the preemption provision of the MDA “does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations; the state duties in such a case ‘parallel,’ rather than add to, federal requirements.” Riegel, 552 U.S. at 330, 128 S.Ct. 999 (first quoting 21 U.S.C. § 360k(a)(1); then quoting Medtronic, Inc. v. Lohr, 518 U.S. 470, 495, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996)); see Lohr, 518 U.S. at 495, 116 S.Ct. 2240 (“Nothing in § 360k denies [a state] the right to provide a traditional damages remedy for violations of common-law duties when those duties parallel federal requirements.”). Supreme Court precedent thus “create[s] a narrow gap through which a plaintiff's state-law claim must fit if it is to escape express or implied preemption.” In re Medtronic, Inc., Sprint Fidelis Leads Prods. Liab. Litig., 623 F.3d 1200, 1204 (8th Cir. 2010) (quoting Riley v. Cordis Corp., 625 F. Supp. 2d 769, 777 (D. Minn. 2009)).

Plaintiffs’ primary allegation in their amended complaint (as well as in their second amended complaint) is that Defendants knew of an increased risk of harm to Mitroflow patients who were under thirty years old at the time of implantation, but that Defendants failed to warn or notify the FDA about this increased risk. See generally [ECF No. 1-1; ECF No. 45]. In analyzing case law from other states and districts at the motion to dismiss stage, the Court found that a state-law claim based on an alleged failure to report information to the FDA was not per se preempted. [ECF No. 26 at 13]. Even so, the Court noted that Plaintiffs had not, at that early stage in the litigation, identified a specific duty to report to the FDA under Massachusetts law. [Id. at 17]. As a result, the Court cautioned that “[i]n order to prevail in this case ․ Plaintiffs will have to demonstrate at a later point in the proceedings that Massachusetts law imposes such a duty.” [Id.].

3. Counts III and V: Negligence and Failure to Warn 3

Defendants primarily argue that Plaintiffs’ negligence and failure to warn claims are preempted because Plaintiffs have failed to demonstrate an essential element of their claims: a duty to report to the FDA under Massachusetts law that is parallel to federal law. [ECF No. 83-1 at 26]. Plaintiffs contend that two Massachusetts courts have found that such a duty exists and that their claims are therefore not preempted. [ECF No. 100 at 6–11].

Under Massachusetts law, the existence of a duty that a defendant owes to a plaintiff is an essential element of both negligence and failure to warn claims. “To prevail on a negligence claim under Massachusetts law, ‘a plaintiff must show by a preponderance of the evidence “(1) a legal duty owed by defendant to plaintiff; (2) a breach of that duty; (3) proximate or legal cause; and (4) actual damage or injury.’ ” ” Primus v. Galgano, 329 F.3d 236, 241 (1st Cir. 2003) (quoting Heinrich v. Sweet, 308 F.3d 48, 62–63 (1st Cir. 2002)). As to a failure to warn claim, the SJC has held that “ ‘a manufacturer of a product, which the manufacturer knows or should know is dangerous by nature or is in a dangerous condition,’ is under a duty to give warning of those dangers to ‘persons who it is foreseeable will come in contact with, and consequently be endangered by, that product.’ ” MacDonald v. Ortho Pharm. Corp., 394 Mass. 131, 475 N.E.2d 65, 68 (1985) (quoting H.P. Hood & Sons v. Ford Motor Co., 370 Mass. 69, 345 N.E.2d 683, 688 (1976)). Under the learned intermediary doctrine, “[w]here the product is a prescription drug ․ it is widely accepted that the manufacturer's duty to warn runs to the physician rather than the patient.” Garside v. Osco Drug, Inc., 976 F.2d 77, 80 (1st Cir. 1992). Massachusetts courts also apply the learned intermediary doctrine to manufacturers of medical devices. See Knowlton v. Deseret Med., Inc., 930 F.2d 116, 120 (1st Cir. 1991); Langlois v. Am. Med. Sys., 462 F. Supp. 3d 1, 4 (D. Mass. 2020); Taupier v. Davol, Inc., No. 19-cv-10184, 2020 WL 5665565, at *11, 2020 U.S. Dist. LEXIS 174276, at *27 (D. Mass. Sep. 23, 2020); see also Albright v. Bos. Sci. Corp., 90 Mass.App.Ct. 213, 58 N.E.3d 360, 368 (2016).

Massachusetts recognizes two types of failure to warn claims: those arising in negligence and those arising under a breach of implied warranty. See Hoffman v. Houghton Chem. Corp., 434 Mass. 624, 751 N.E.2d 848, 859 (2001). It appears that Plaintiffs intended to plead a claim of negligent failure to warn. [ECF No. 45 ¶¶ 114–15 (referencing negligence in connection with failure to warn claim)]. Regardless of whether Plaintiffs intended to plead negligent failure to warn or breach of implied warranty failure to warn, however,

[t]he Supreme Judicial Court has effectively collapsed the two standards for negligence and breach of warranty where the plaintiffs’ allegations are based upon a failure to warn, determining that “negligent failure to warn and failure to warn under breach of warranty are to be judged by the same standard: the reasonableness of the defendant's actions in the circumstances.”

Calisi v. Abbott Labs., No. 11-cv-10671, 2013 WL 5441355, at *14, 2013 U.S. Dist. LEXIS 139257, at *46 (D. Mass. Sep. 27, 2013) (quoting Hoffman, 751 N.E.2d at 859); see Kotler v. Am. Tobacco Co., 926 F.2d 1217, 1230 (1st Cir. 1990) (“[T]he distinction between negligence actions and breach of warranty actions blurs considerably when the suit emanates from an alleged omission adequately to warn of a product's dangers.”), vacated, 505 U.S. 1215, 112 S.Ct. 3019, 120 L.Ed.2d 891 (1992), aff'd on remand, 981 F.2d 7 (1st Cir. 1992).

As Plaintiffs acknowledge, their case is focused on Defendants’ alleged failure to make adequate reports to the FDA regarding adverse events associated with use of the Mitroflow in patients under thirty years of age. See [ECF No. 45; ECF No. 115 at 5 (Plaintiffs’ sur-reply, stating, “the entire basis of Plaintiffs’ claims is that certain information that should have been reported by Defendants was never reported and never made it into the public eye”)]. Plaintiffs’ negligence claim is premised on Defendants’ alleged failure to report data to the FDA, see [ECF No. 45 ¶ 83 (describing negligence claim as “specifically the failure to update the FDA after the PMA process”)], and their failure to warn claim is premised on Defendants’ alleged failure to make adequate reports to the FDA, see [id. ¶ 112 (alleging “failure to properly update the FDA and provide more specific and accurate warnings”)]. According to Plaintiffs, had the FDA received this information, the FDA would have made the information public, giving doctors and patients additional information about the risks of using the Mitroflow in patients under thirty. See [ECF No. 45 ¶¶ 101–15]. Under Plaintiffs’ theory of the case, then, both their negligence and failure to warn claims require them to show that Defendants had a duty to report events to the FDA. As noted above, at the motion to dismiss stage, the Court advised Plaintiffs of their obligation to identify a duty to report to the FDA under Massachusetts law in order to save their claims from preemption. [ECF No. 26 at 17].⁴ Plaintiffs have failed to meet this obligation.

First, Plaintiffs rely on a 2004 Massachusetts Superior Court decision, Scoggins v. Bos. Sci. Corp., No. 07-cv-4049, 2010 WL 8911977, 2010 Mass. Super. LEXIS 2988 (Oct. 18, 2010), to establish Defendants’ duty to report to the FDA under Massachusetts law. [ECF No. 100 at 6–10, 15–16]. But as the Court stated in its Order on the motion to dismiss, [ECF No. 26 at 11 n.4], the court in Scoggins merely observed that such a duty might be found to exist under Massachusetts law without finding that one does, in fact, exist. Scoggins, 2010 WL 8911977, at *14, 2010 Mass. Super. LEXIS 2988, at *39 (“The parties have not addressed, and I therefore do not now decide, whether a claim that the manufacturer failed to warn the FDA of adverse events associated with particular off-label uses, and that therefore the FDA did not require a warning concerning them, is consonant with the learned intermediary rule ․”).

Second, Plaintiffs cite to a 2007 Massachusetts Superior Court case, Brown v. DePuy Spine, Inc., No. 06-00208, 2007 WL 1089337, 2007 Mass. Super. LEXIS 114 (Mass. Super Ct. Apr. 9, 2007), for the same proposition. [ECF No. 100 at 6–10, 15–16]. In Brown, the court was faced with motions for summary judgment based on preemption, though the motions were filed early in the case and prior to discovery. 2007 WL 1089337, at *7, 2007 Mass. Super. LEXIS 114, at *20. Like Scoggins, the court found that there could be a parallel duty to report to the FDA without definitively identifying or recognizing such a duty under Massachusetts law, id. at *11, 2007 Mass. Super. LEXIS 114, at *40–42, but declined to resolve the issue at the early stages of the litigation, id. at *13, 2007 Mass. Super. LEXIS 114, at *42 (“In any event, there has not yet been any significant discovery. Where an underlying question of law is subject to doubt, the preferable practice is to decide the question on a full record of facts.”).⁵

Thus, Plaintiffs have not identified binding or persuasive authority that manufacturers of medical devices have a common law or statutory duty to report adverse events to the FDA. In addition, Plaintiffs have not identified any basis for extending the learned intermediary doctrine under a failure to warn theory so as to require manufacturers to report to or warn the FDA of dangers. See Garside, 976 F.2d at 80 (describing duty under learned intermediary doctrine as a manufacturer's duty to warn physicians). The Court therefore concludes that Plaintiffs have not met their burden of demonstrating that there is a Massachusetts law that requires manufacturers to make reports to the FDA, nor is the Court aware of such a law. Accordingly, absent a showing of a state law that parallels the requirements under federal law, Plaintiffs’ claims that Defendants had a duty to warn the FDA of harm is different from federal law and therefore preempted. See Riegel, 552 U.S. at 330, 128 S.Ct. 999.⁶

Other jurisdictions with similar state law failure to warn provisions have found that a duty to warn doctors under the learned intermediary doctrine does not correspondingly impose a duty to report to the FDA. For example, in 2017, the Arizona Supreme Court expressly found that the Ninth Circuit misinterpreted Arizona law in Stengel v. Medtronic Inc., 704 F.3d 1224, 1232 (9th Cir. 2013) (en banc), and held that Arizona law does not impose a duty to warn the FDA in connection with a common law failure to warn claim, Conklin v. Medtronic, Inc., 245 Ariz. 501, 431 P.3d 571, 579 (2018). The Conklin court observed that Arizona “case law contemplates that a medical device manufacturer may satisfy its duty to warn consumers by properly warning a third party, such as a learned intermediary. But the FDA is not a learned intermediary or other relevant third party in that analysis.” Id. (citation omitted). As a result, the court held that

[b]ecause only federal law, not state law, imposes a duty on [defendant] to submit adverse event reports to the FDA, [plaintiff's] failure-to-warn claim is impliedly preempted under 21 U.S.C. § 337(a). Absent an independent state law duty to submit adverse event reports to the FDA, [plaintiff's] failure-to-warn claim, at bottom, is an attempt to enforce a federal law requirement. That claim is impliedly preempted under the MDA.

Id. at 578 (citation omitted).

Similarly, the Illinois Court of Appeals issued an opinion interpreting Illinois’ failure to warn law—which, like Massachusetts, applies the learned intermediary doctrine—to find that the duty to warn did not compel manufacturers to warn the FDA. Norabuena v. Medtronic, Inc., 416 Ill.Dec. 913, 86 N.E.3d 1198, 1207 (App. Ct. 2017).⁷ In interpreting Illinois law, the Illinois Court of Appeals held that,

[a]lthough Illinois recognizes that a manufacturer may satisfy its duty to warn by conveying information to third-party learned intermediaries, this is not synonymous with an affirmative duty to warn a federal regulatory body. The learned intermediary doctrine states that a manufacturer has a duty ‘to warn prescribing physicians of a drug's known dangerous propensities’ under the understanding that those physicians will use their expert knowledge in adequately warning the patient. We cannot find that this duty is parallel to the federal requirement.

Id. (citations omitted).

This refusal to extend the learned intermediary doctrine so as to impose an obligation on manufacturers to report to or warn the FDA is consistent with recent decisions from other jurisdictions. See, e.g., McNeil-Williams v. Depuy Orthopaedics, Inc., No. 18-cv-00220, 2019 WL 2179217, at *4, 2019 U.S. Dist. LEXIS 84339, at *10 (E.D.N.C. May 20, 2019) (“Plaintiff's primary asserted theory of negligence liability fails, however, because North Carolina law does not recognize a parallel duty on manufacturers to report to the FDA as plaintiff asserts. Rather, North Carolina law recognizes a duty to warn only users or medical practitioners in certain circumstances.”); Kubicki ex rel. Kubicki v. Medtronic, Inc., 293 F. Supp. 3d 129, 184 (D.D.C. 2018) (“[T]he common law failure to warn claim is not, in fact, the functional equivalent of a manufacturer's failure to report adverse incidents to the FDA in violation of federal law.”); Aaron v. Medtronic, Inc., 209 F. Supp. 3d 994, 1004–06 (S.D. Ohio 2016) (finding state law failure to warn claim preempted because Ohio law requires manufacturers to warn patients or physicians, but not the FDA); Pearsall v. Medtronics, Inc., 147 F. Supp. 3d 188, 200–01 (E.D.N.Y. 2015) (state law failure to warn claim preempted because New York law requirement that manufacturers warn the medical profession “is not the same as a duty to report to the FDA”); Pinsonneault v. St. Jude Med., Inc., 953 F. Supp. 2d 1006, 1015 (D. Minn. 2013) (finding state law duty to warn claim preempted where plaintiffs could not identify state law that imposed duty to warn the FDA, rather than patients and doctors).

Because there is an “overarching mandate that the state claim and the federal claim must be genuinely—as opposed to effectively—equivalent,” Kubicki, 293 F. Supp. 3d at 183–84, Plaintiffs have failed to identify a parallel duty under Massachusetts law that would have required Defendants to make reports to the FDA coextensive with the requirements imposed by federal law. Because “a complete failure of proof concerning an essential element of the nonmoving party's case necessarily renders all other facts immaterial,” summary judgment for Defendants is GRANTED as to Counts III and V. Celotex, 477 U.S. at 323, 106 S.Ct. 2548; see Tobin v. Fed. Express Corp., 775 F.3d 448, 452 (1st Cir. 2014) (affirming summary judgment for defendant where plaintiff failed to meet essential element of claim).

4. Count II: Breach of Warranty

Plaintiffs’ second amended complaint alleges a breach of warranty, stating that Defendants breached either express or implied warranties. [ECF No. 45 ¶¶ 63, 69]. As noted above, Plaintiffs have failed to meet an essential element—duty—of a breach of implied warranty claim based on a failure to warn. See supra, Section III.C.3.

In their opposition to summary judgment, Plaintiffs focus on Defendants’ alleged breach of an express warranty, arguing “that Defendants warranted the safety and utility of Mitroflow, through statements made to health care providers and patients.” [ECF No. 100 at 13]. Defendants argue that this claim, too, is preempted, [ECF No. 83-1 at 24 n.6], which Plaintiffs dispute, [ECF No. 100 at 13]. Even assuming arguendo that Plaintiffs’ breach of express warranty claim is not preempted, the Court finds that Plaintiffs have failed to put forward an express warranty claim that can survive summary judgment.

“The theory underlying a breach of express warranty claim is that ‘defendants are liable to the plaintiff for failure to provide a [product] that meets a standard of performance allegedly promised by the defendants.’ ” Jackson v. Johnson & Johnson & Janssen Pharm., Inc., 330 F. Supp. 3d 616, 627 (D. Mass. 2018) (quoting Anthony's Pier Four, Inc. v. Crandall Dry Dock Eng'rs, Inc., 396 Mass. 818, 489 N.E.2d 172, 175 (Mass. 1986)). “Because the standard of performance is set by defendant's express promises to the plaintiff, ‘the plaintiff must demonstrate that the defendant promised a specific result’ and that defendant failed to deliver on his promise and, therefore, breached the express warranty.” Id. (quoting Anthony's Pier Four, 489 N.E.2d at 175). Where express warranties are accompanied by limitations or warnings, however, they “must be construed in a manner consistent with language purporting to negate or limit warranties.” Stuto v. Corning Glass Works, No. 88-cv-01150, 1990 WL 105615, at *6, 1990 U.S. Dist. LEXIS 9320, at *19 (D. Mass. July 23, 1990) (quoting Gilbert & Bennett Mfg. Co. v. Westinghouse Elec. Corp., 445 F. Supp. 537, 546 (D. Mass. 1977)); see also Hiam v. HomeAway.com, Inc., 267 F. Supp. 3d 338, 352 (D. Mass. 2017) (reading guarantee in combination with terms and conditions to find that any express warranty was limited by those terms and conditions).

Plaintiffs allege that Defendants “offer[ed] exaggerated and misleading expectations as to the safety and utility of the Mitroflow” and thus “warranted that it was safe and fit for the purposes of treating patients with heart conditions under the age of thirty (30) years with only minimal risk of failure.” [ECF No. 45 ¶ 63]. Yet Plaintiffs do not dispute that the IFU for the Mitroflow contained an explicit warning regarding use of the product in juveniles and individuals under fifty-five years old. [SOF ¶ 12; ECF No. 86-4 at 2 (“Clinical experience described in the medical literature suggests that juvenile patients or patients who are undergoing chronic hemodialysis, who have parathyroid disease or impaired calcium metabolism, or who are 55 years of age or less may experience accelerated calcification of bioprosthetic heart valves.”)]. Nor do Plaintiffs identify any specific statements that Defendants made to them or to Allison's treating physicians, Drs. Baird and Pigula, that would be understood as a guarantee or warranty of the Mitroflow's suitability in patients under thirty years of age. See [ECF Nos. 45 (second amended complaint), 99 (Separate SOF)].

“While ‘in general, the question whether certain language creates an express warranty is reserved for the trier of fact,’ as matter of law, the Court concludes here that” Plaintiffs have not identified any statements that could be interpreted to “create the alleged promises,” particularly where the Mitroflow's IFU contained an explicit warning regarding use of the device in younger individuals. Hiam, 267 F. Supp. 3d at 352 (D. Mass. 2017) (quoting Sullivan v. Young Bros. & Co., 91 F.3d 242, 247 (1st Cir. 1996)); see Chapman ex rel. Chapman v. Bernard's, Inc., 167 F. Supp. 2d 406, 414 (D. Mass. 2001) (granting summary judgment for defendant where plaintiff failed to produce evidence of an express warranty). As a result, even “indulging all reasonable inferences” in Plaintiffs’ favor, Cochran, 328 F.3d at 6, summary judgment for Defendants is GRANTED as to Count II.

5. Count VII: Chapter 93A

Defendants argue that Plaintiffs’ Chapter 93A claim is derivative of their other claims and therefore must also fail, [ECF No. 83-1 at 32 n.8], while Plaintiffs contend that their Chapter 93A claim is not preempted, [ECF No. 100 at 16].

Chapter 93A creates a private cause of action against those who engage in “unfair or deceptive acts or practices in the conduct of any trade or commerce.” Mass. Gen. Laws ch. 93A, § 2(a). “Although Chapter 93A claims are often linked with and derivative of other statutory and common law claims for relief, it is settled law that Chapter 93A supplies an independent cause of action ․ [a]s long as a litigant offers separate arguments in support of her Chapter 93A claim․” Reed v. Zipcar, Inc., 883 F. Supp. 2d 329, 334–35 (D. Mass. 2012) (citation omitted).

Here, Plaintiffs’ Chapter 93A allegations are derivative of their other claims in that they allege that “Defendants’ failure to provide accurate information to the FDA was an unfair and deceptive trade practice.” [ECF No. 45 ¶ 136]. Plaintiffs in fact acknowledge that this claim is derivative of their other claims by noting that “[t]o the extent Plaintiffs’ state-law tort claims survive ․ so to[o] do their claims pursuant to Chapter 93A.” [ECF No. 100 at 16]; see also [ECF No. 115 at 5 (stating that “the entire basis of [their] claims is that certain information that should have been reported by Defendants was never reported”)]. The First Circuit recently affirmed dismissal of a plaintiff's Chapter 93A claim based on preemption to the extent that the plaintiff alleged that “mislabeling[ ] and misbranding [under federal law] constitutes unfair and deceptive conduct in violation of [chapter] 93A.” Dumont v. Reily Foods Co., 934 F.3d 35, 42 (1st Cir. 2019) (alterations in original) (allowing only those Chapter 93A allegations that were untethered to FDA regulations to move forward); see Talbott v. C.R. Bard, Inc., 865 F. Supp. 37, 52 (D. Mass. 1994) (“Plaintiffs’ claim under Mass. Gen. L. ch. 93A has the potential to impose state requirements in addition to, or different than, the FDA's requirements. It is, therefore, preempted.”), aff'd 63 F.3d 25 (1st Cir. 1995).

Having failed to offer evidence that Defendants engaged in unfair or deceptive practices separate and apart from allegations concerning reporting obligations to the FDA, summary judgment for Defendants is GRANTED as to Count VII. See Phillips, 2012 WL 3641487, at *3, 8, 2012 Mass. Super. LEXIS 3435, at *23, 29 (dismissing Chapter 93A claims along with related claims regarding failure to report adverse events to the FDA); see also Skehel v. DePaulis, No. 13-cv-11202, 2017 WL 2380164, at *3, 2017 U.S. Dist. LEXIS 83930, at *7 (D. Mass. June 1, 2017) (entering judgment for defendants on Chapter 93A claim that was derivative of failed negligence and breach of contract claims); Town of Lexington v. Pharmacia Corp., 133 F. Supp. 3d 258, 272 (D. Mass. 2015) (granting summary judgment for defendant on Chapter 93A claim that was derivative of a failed breach of implied warranty claim).

IV. MOTIONS TO EXCLUDE

Plaintiffs’ experts Tomes and Stevens were being offered to provide expert testimony on Defendants’ reporting obligations to the FDA and compliance protocols, while Dr. Pigula was being offered as an expert on causation. Because the Court has resolved Defendants’ motion for summary judgment without reaching Defendants’ specific reporting obligations to the FDA or causation, Defendants’ motions to exclude, [ECF Nos. 73, 76, 79], are DENIED as moot.

V. CONCLUSION

Accordingly, for the reasons discussed herein, Plaintiffs’ Counts I, IV, and VI are DISMISSED as being inconsistent with the Court's previous Order on Defendants’ motion to dismiss. Defendants’ motion for summary judgment on Counts II, III, V, and VII, [ECF No. 82], is GRANTED. Defendants’ motion to strike, [ECF No. 108], is GRANTED in part, and Defendants’ motions to exclude, [ECF Nos. 73, 76, 79], are DENIED as moot.

SO ORDERED.

FOOTNOTES

1.   Mechanical valves are metallic and require patients to take Coumadin, a blood thinner, daily. [SOF ¶¶ 69–71].

2.   In Plaintiffs’ Separate SOF, Plaintiffs assert that Dr. Baird expected the Mitroflow to last ten years at the time of implant. [ECF No. 99 at 2]. Dr. Baird's deposition testimony, however, indicates that he could not recall how long he expected the Mitroflow to last in Allison's case, though in general he would have expected the valve to last ten years. [ECF No. 101-3 at 5].

4.   “Federal ‘preemption is an affirmative defense on which [the] defendant bears the burden of proof.’ ” Bartlett v. Mut. Pharm. Co., Inc., 659 F. Supp. 2d 279, 281 (D.N.H. 2009) (quoting Cambridge Literary Props., Ltd. v. W. Goebel Porzellanfabrik G.m.b.H. & Co. KG, 510 F.3d 77, 102 (1st Cir. 2007)). Other courts have employed the burden-shifting framework the Court adopts here in the context of express or implied preemption, finding that it is a plaintiff's burden “to establish that the state law claims it seeks to maintain are truly parallel to the federal requirements at issue, and that the alleged breach of these parallel duties caused the plaintiff's injury.” Kubicki ex rel. Kubicki v. Medtronic, Inc., 293 F. Supp. 3d 129, 172 (D.D.C. 2018); see also Wolicki-Gables v. Arrow Int'l, Inc., 634 F.3d 1296, 1300 (11th Cir. 2011); McMullen v. Medtronic, Inc., 421 F.3d 482, 489 (7th Cir. 2005); Bird v. Globus Med., Inc., No. 19-cv-01024, 2020 WL 5366300, at *4, 2020 U.S. Dist. LEXIS 164480, at *11 (E.D. Cal. Sept. 4, 2020); Martin v. Medtronic, Inc., 32 F. Supp. 3d 1026, 1034 (D. Ariz. 2014). But see In re Zofran (Ondansetron) Prods. Liab. Litig., 368 F. Supp. 3d 94, 114–15 (D. Mass. 2019) (declining to adopt burden-shifting framework in context of conflict preemption).

5.   In a supplemental filing, Plaintiffs notified the Court of a recent decision from the Massachusetts Supreme Judicial Court (“SJC”) which discussed preemption in the context of pleading standards at the motion to dismiss stage. [ECF No. 121]. The SJC, consistent with this Court's Order on Defendants’ motion to dismiss, held that a plaintiff's parallel state law claims are not automatically subject to preemption. Dunn v. Genzyme Corp., 486 Mass. 713, 161 N.E.3d 390, 2021 Mass. LEXIS 84 (2021). Absent from the SJC's opinion, however, was a statement that the duty Plaintiffs seek to invoke here exists under Massachusetts law so as to parallel federal regulations, nor is it apparent that the plaintiff's allegations in Dunn ran to FDA reporting obligations. See id.

6.   In its Order on the motion to dismiss, the Court declined to follow a Massachusetts Superior Court decision, Phillips v. Medtronic, Inc., No. 2009-05286, 2012 WL 3641487, at *10, 2012 Mass. Super. LEXIS 3435, slip. op. at *28 (Mass. Super. Ct. July 10, 2012), which found that no such duty exists under Massachusetts common law, [ECF No. 26 at 11–12]. The Court's decision not to follow Phillips was due in part to the fact that case law that the Phillips court relied on in 2012 had, at the time of this Court's 2018 Order, been called into question. [ECF No. 26 at 12–13 (citing, among other cases, Stengel v. Medtronic Inc., 676 F.3d 1159, 1164 (9th Cir. 2012), rev'd en banc, 704 F.3d 1224, 1232 (9th Cir. 2013))]. Now, nearly three years after the Court's 2018 Order, however, several of those cases have been challenged or reversed so that Phillips is now realigned with current views of the issue. These changes are discussed infra.

7.   This holding is therefore counter to the Seventh Circuit's earlier interpretation of Illinois law in Bausch v. Stryker Corp., 630 F.3d 546, 558 (7th Cir. 2010), which the Court relied on, in part, in its Order on Defendants’ motion to dismiss, see [ECF No. 26 at 10–13].

BURROUGHS, U.S. DISTRICT JUDGE